The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.

The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.

Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Successful recanalization of the CTO defined as:

Confirmation of placement of the guide wire in the distal true lumen (component 1)

Absence of in-hospital MACE, based on ARC MI (component 2)

Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Successful recanalization of the CTO defined as:

Confirmation of placement of the guide wire in the distal true lumen (component 1)

Absence of in-hospital MACE, based on protocol MI (component 2)

Angioplasty Predilatation-related: Successful Predilatation of the CTO [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and;

Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure

Secondary Outcome Measures:

Minimum Lumen Diameter (MLD): Pre-procedure [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.

Minimum Lumen Diameter (MLD): Post-procedure [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory.

Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

TIMI Classification:

TIMI 0 No perfusion.

TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.

TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.

TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.

Change in TIMI Flow Grade: Post-procedure [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

TIMI Classification:

TIMI 0 No perfusion.

TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.

TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.

TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.

Device Success [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Procedure Success [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Device success and absence of in-hospital MACE.

Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).

Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment.

Procedural Success With Antegrade Crossing [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol

Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol; antegrade crossing method

Procedural Success With Knuckle Wire [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol; antegrade crossing method

Procedural Success With Primary Retrograde Wire Crossing [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol

Procedural Success With Controlled Antegrade-Retrograde Technique (CART) [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol

Procedural Success With Reverse CART [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol

Procedural Success With Kissing Wire Technique [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol; combined antegrade and retrograde crossing method

Procedural Success With Sub Intimal Technique [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol

Procedural Success With Multiple Crossing Techniques [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

per protocol

Resource Utilization: Procedural Time [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Resource Utilization: Fluoroscopic Time [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Resource Utilization: Contrast Volume [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

Clinically Significant Perforation [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Stent Thrombosis [ Time Frame: Subacute (>24 hours to 30 days) ]

Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Stent Thrombosis [ Time Frame: Late (>30 days to 1 year) ]

Academic Research Consortium (ARC) criteria; definite and probable.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Stent Thrombosis [ Time Frame: 1 year ]

Academic Research Consortium (ARC) criteria; definite and probable.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Stent Thrombosis [ Time Frame: 2 years ]

Academic Research Consortium (ARC) criteria.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Stent Thrombosis [ Time Frame: 3 years ]

Academic Research Consortium (ARC) criteria.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Stent Thrombosis [ Time Frame: 4 years ]

Academic Research Consortium (ARC) criteria.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Stent Thrombosis [ Time Frame: 5 years ]

Academic Research Consortium (ARC) criteria.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Subject is willing and able to sign an informed consent form (ICF) approved by a local Institutional Review Board/Ethics Committee and to follow the protocol with up to 5-year follow up.

Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before enrollment and effective birth control must be used up to 1 year following the index procedure.

Angiographic Inclusion Criteria

A maximum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. A "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram:

High-grade native coronary stenosis

TIMI 0 or 1 antegrade flow

Occluded segment suitable for placement of coronary stents:

Segment without severe tortuosity (angulation ≥ 45º)

Segment not located in an excessively distal location

General Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions are present:

Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, stainless steel, or everolimus

Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin)

Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement (including, but not limited to directional or rotational coronary atherectomy, excimer laser, thrombectomy, etc.). Note: Use of alternative technologies to conventional guide wires that are approved by the United States Food and Drug Administration for CTO revascularization (e.g., Asahi Tornus and Corsair catheters, IntraLuminal Therapeutics Safe Cross guide wire, Flowcardia CROSSER system) is permitted and will be collected in the case report form.

Patients with history of clinically significant abnormal laboratory findings including:

History of bleeding diathesis or coagulopathy or refusal of blood transfusions

Patients with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study.

Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements.

Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS), or other coronary artery imaging procedures

Angiographic Exclusion Criteria

Candidates will be excluded from study if any of the following conditions are met:

Occlusion involves segment within previous stent

Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)

Previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:

It has been at least 9 months since the previous stenting.

That target lesion is at least 15 mm away from the previously placed stent.

The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.

The target vessel has other lesions proximal to the total occlusion identified with greater than 40% diameter stenosis based on visual estimate or on-line quantitative coronary angiography (QCA). However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (ie, tandem lesions) are acceptable.

Exclusion Criteria (Non-target Lesion):

The lesion is located in a native vessel distal to anastomosis with a graft.

The vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.

The vessel has evidence of thrombus.

The vessel is excessively tortuous.

The lesion has any of the following characteristics:

Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA).

Involves a side branch > 2.0 mm in diameter.

Is at or distal to a > 45º bend in the vessel.

Is moderately to severely calcified.

TIMI flow 0 or 1.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01435031